MUSCLE AND JOINT PAIN RELIEF GEL- menthol, eucalyptus globulus leaf oil gel 
Dimensional Merchandising Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MUSCLE & JOINT PAIN RELIEF GEL

Drug Facts

Active Ingredients

Menthol 5.0%

Eucalyptus Globulus Leaf Oil 3.25%

Purpose

Topical Analgesic

Uses:

Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises and sprains.

Warnings:

For external use only.

Do Not Use: On wounds or damaged skin, with a heating pad, or on a child under 12 years of age with arthritis-like conditions.

Ask a Doctor Before Use If You Have: Redness over the affected area.

When Using This Product: Avoid contact with eyes or mucous membranes; do not bandage tightly.

Stop Use and Ask Doctor If: Condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days, or if redness is present or excessive skin irritation develops.

CAUTION: Keep away from eyes. Wash hands and fingers thoroughly.

Keep Out of Reach of Children:

 In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Directions:

Use only as directed. After use, wipe off applicator head and replace protective cap. Clean outside with damp cloth or paper towel. Do not rinse under or immerse in water.

Adults and children 12 years of Age and older: apply to affected area not more than 3 to 4 times daily.

Children Under 12 years of Age: consult a doctor.

Other Information: Store between 20 and 25 °C (68 and 77 °F)

Other Ingredients:

Water, Alcohol Denatured, Glycerin, Piper Methysticum Leaf/Root/Stem Extract, Calendula Officinalis Flower Extract, Arnica Montana Flower Extract, Carbomer, Butylene Glycol, Propylene Glycol, Polysorbate 20, Chlorphenesin, Sodium Hydroxide, Sodium Benzoate, Potassium Sorbate.

NatureWell™ CLINICAL

WITH KAVA EXTRACT

MUSCLE STRAINS

JOINT PAIN

STRAINS AND CRAMPS

TEMPORARY PAIN RELIEF • SOOTHES ACHES & PAINS • QUICK VANISHING ODOR

FAST-ACTING • NON-GREASY • QUICK-DRY FORMULA 

HANDS FREE ROLLER BALL APPLICATION

MESS-FREE MASSAGING APPLICATOR

No Parabens • Dye-Free

Not Tested on Animals

Formula Made in the USA

Soothe aching muscles and joints with NatureWell™ Clinical 

In an easy to use roll-on applicator, this product glides on for targeted, cooling relief. Formulated with 5% Menthol and 3.25% Eucalyptus Oil to reduce aches and pain. This no-mess, fast acting gel temporarily alleviates any aches or pains. Great for muscle strains, sprains and cramps.

BENEFITS

KEY INGREDIENTS

DISTRIBUTED BY:

NATUREWELL™

PHOENIX, AZ 85016

Packaging

image description

MUSCLE AND JOINT PAIN RELIEF GEL 
menthol, eucalyptus globulus leaf oil gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61383-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL3.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61383-701-012 in 1 BLISTER PACK11/16/2016
1NDC:61383-701-9696 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/16/2016
Labeler - Dimensional Merchandising Inc. (076693183)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc.076693183manufacture(61383-701)

Revised: 11/2016
Document Id: de53d1ea-149f-416c-8cb3-00e60c53970b
Set id: 53a1e60f-f641-4aed-874a-efcb13dc1074
Version: 1
Effective Time: 20161116
 
Dimensional Merchandising Inc.